Manager/Senior Manager, QC Microbiology

A rapidly growing biotech organization is growing out their microbiology team! This is not a bench position. This position is more centered towards contamination control and method validation. See the key responsibilities below:

Sterility Assurance and Contamination Control

Ensure the site's compliance with sterile processing and contamination control standards, including environmental monitoring, clean-room management, and sterilization.

Develop and maintain strategies to control microbial contamination and cross-contamination.

Support the development of contamination control strategies and maintain risk assessments related to microbial contamination.

Environmental Monitoring and Utilities

Oversee environmental monitoring programs, including utilities and trending reports for compliance and technical accuracy.

Develop strategies for effective environmental monitoring and oversee site-wide testing for contamination.

Technical Writing and Communication

Author and revise procedures and technical documents for sterility assurance.

Communicate with senior management about contamination control issues.

Participate in continuous improvement initiatives and promote best practices for contamination control.

Microbiological Expertise

Ensure compliance with global standards and regulations for microbiology and sterility assurance.

Troubleshoot contamination issues and support related investigations.

Provide oversight for microbiological testing performed in-house and at contract laboratories.

Microbial method validations.

Key Qualifications:

Bachelor’s degree in the Microbiology, Life Science, or related field.

Minimum of 5 years of QC Microbiology experience in the pharma/biotech industry.

Experience with rapid microbial test methods: sterility, endotoxin, and/or mycoplasma

Experience in microbial contamination control.

Experience with microbiological risk assessments.

Experience with cell therapy products is a plus.